Identifying Required Study Personnel

As you prepare to conduct a clinical research study at Massachusetts General Hospital, it is important to identify the specific skills needed in your research team, and to identify personnel to fill those roles.

What skill sets will your staff members need in order to perform the required tasks?

Who will conduct screening procedures, collect and enter study data, and review data for completeness and accuracy?

How many hours will it take to complete these tasks?

What additional trainings are needed?

Once you have determined the scope of the work required for your project and outlined the study staff’s roles and responsibilities, this information can be entered into the protocol’s Regulatory Binder delegation of responsibility log.

In addition to study staff protocol-specific roles and responsibilities, principal investigators are ultimately responsible for managing their study funds. You must determine who on your study team or your department’s administrative staff will monitor your study funds to assure that expenses charged to the fund are correct and who will be responsible for correcting errors.

Learn More

The Division of Clinical Research (DCR) at Massachusetts General Hospital helps to connect investigators and study staff members to a variety of courses, services and resources that provide assistance with every step of the clinical research process. These resources include offerings from the DCR itself, as well as associated research institutions and organizations. Mass General resources are listed first; DCP programs are noted in parentheses.

Resources

Partners QI Program Electronic Regulatory Binder: To request a copy of the project for an IRB approved protocol: login to REDCap with your Partners username and password, click the tab titled “Request New Project” and complete the fields for requesting the Electronic Regulatory Binder template.